Chronic Nonspecific Low Back PainNCT01919268
Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain
A study testing Electrotherapy and Pilates in people with Chronic Nonspecific Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Electrotherapy and Pilates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary patients with chronic nonspecific low back pain longer than 12 weeks
- Pain greater than three points in Pain Numerical Rating Scale
Who cannot join
- Contra indications to physical exercise
- Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
- Nerve root compromise
- Pregnancy
- Infection and/or skin lesions at the site of the application of the interferential current
- Cancer
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- Cardiac pacemaker
- Changes in sensitivity or allergy in the region of electrode placement
- Previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months
- Previous experience with the Pilates method
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Therapy Outpatient Department
São Paulo, São Paulo, 03071000
About this study
Official title: Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Electrotherapy, Pilates
- Keywords
- Pilates-based exercises, Electrotherapy, Interferencial current
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrotherapyDevice
Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).
PilatesDevice
Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).
| Study group | Role | What they receive |
|---|---|---|
| Electrotherapy | Experimental | Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment). Receives: Device: Electrotherapy |
| Pilates | Active comparator | Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of six weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment). Receives: Device: Pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Measured: Six weeks after randomization
Pressure pain threshold
Pressure pain threshold will be evaluated using a pressure algometer
Measured: Six weeks after randomization
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Six weeks after randomization
Secondary outcomes (5)
Pain intensity
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
Measured: Six months after randomization
Disability
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Measured: Six months after randomization
Global impression of recovery
Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale
Measured: Six weeks and six months after randomization
Specific disability
Specific disability will be evaluated by an 11-point Patient-specific Functional Scale
Measured: Six weeks and six months after randomization
Kinesiophobia
Kinesiophobia will be evaluated by the Tampa Scale for Kinesiophobia
Measured: Six weeks and six months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919268
- Sponsor's protocol ID
- CAAE 18034113.7.0000.0064
- Status last verified
- Jun 2015
- First submitted
- 7 Aug 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franco KM, Franco YD, Oliveira NB, Miyamoto GC, Santos MO, Liebano RE, Cabral CN. Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain?: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):320-328. doi: 10.1016/j.apmr.2016.08.485. Epub 2016 Oct 19.
PubMed 27771359Franco YR, Liebano RE, Moura KF, de Oliveira NT, Miyamoto GC, Santos MO, Cabral CM. Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:420. doi: 10.1186/1471-2474-15-420.
PubMed 25492853
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Addition of the Interferential Current to the Pilates Method in the Treatment of Patients With Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01919268
- Acronym / sponsor ID
- CAAE 18034113.7.0000.0064
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Pilates-based exercises, Electrotherapy, Interferencial current
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of the addition of the interferential current to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrotherapy | Experimental | Device: ElectrotherapyCombination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment). |
| Pilates | Active comparator | Device: PilatesCombination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of six weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sedentary patients with chronic nonspecific low back pain longer than 12 weeks
- Pain greater than three points in Pain Numerical Rating Scale
Key exclusion criteria (10 listed)
- Contra indications to physical exercise
- Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
- Nerve root compromise
- Pregnancy
- Infection and/or skin lesions at the site of the application of the interferential current
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrotherapyCombination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment). | Device | Electrotherapy |
| PilatesCombination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment). | Device | Pilates |
Primary outcome
Disability
Time frame: Six weeks after randomization
Disability associated with low back pain will be measured by the 24-item Rolland Morris Disability Questionaire
Pressure pain threshold
Time frame: Six weeks after randomization
Pressure pain threshold will be evaluated using a pressure algometer
Pain intensity
Time frame: Six weeks after randomization
Pain intensity will be measured by an 11-point Pain Numerical Rating Scale
5 secondary outcomes
Pain intensity
Time frame: Six months after randomization
Disability
Time frame: Six months after randomization
Global impression of recovery
Time frame: Six weeks and six months after randomization
Specific disability
Time frame: Six weeks and six months after randomization
Kinesiophobia
Time frame: Six weeks and six months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Derived from this study: PubMed 27771359Franco KM, Franco YD, Oliveira NB, Miyamoto GC, Santos MO, Liebano RE, Cabral CN. Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain?: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Feb;98(2):320-328. doi: 10.1016/j.apmr.2016.08.485. Epub 2016 Oct 19.
- Derived from this study: PubMed 25492853Franco YR, Liebano RE, Moura KF, de Oliveira NT, Miyamoto GC, Santos MO, Cabral CM. Efficacy of the addition of interferential current to Pilates method in patients with low back pain: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:420. doi: 10.1186/1471-2474-15-420.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy and Pilates in people with Chronic Nonspecific Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: Six weeks after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.